{
  "format": "devicerts.device.v1",
  "cite_as": "Volumetric Specimen Imager, Clarix Imaging. deviCERTS medical device catalogue. https://devicerts.com/devices/volumetric-specimen-imager-mwp (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/volumetric-specimen-imager-mwp",
    "json_url": "https://devicerts.com/devices/volumetric-specimen-imager-mwp.json",
    "markdown_url": "https://devicerts.com/devices/volumetric-specimen-imager-mwp.md",
    "publisher": "deviCERTS (devicerts.com)",
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/volumetric-specimen-imager-mwp",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Volumetric Specimen Imager",
    "registry_name": "Volumetric Specimen Imager",
    "url": "https://devicerts.com/devices/volumetric-specimen-imager-mwp",
    "manufacturer": {
      "name": "Clarix Imaging",
      "url": "https://devicerts.com/manufacturers/clarix-imaging",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
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      "label": "Active",
      "detail": "United States"
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    "classification": [
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        "class": "Class II",
        "system": "US FDA"
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          {
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        ]
      }
    ],
    "product_codes": [
      "MWP"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Volumetric Specimen Imager is a cabinet X-ray system designed for radiology applications. It provides two- and three-dimensional digital imaging of specimens.\n\nThe device is supplied as a non-sterile, reusable system intended for use in clinical imaging settings. It has received FDA 510(k) clearance under product code MWP and regulation number 892.1680, with the manufacturer located at 2242 Harrison St. Suite 201, Chicago, IL 60612.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
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    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K192939",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-12-27",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": false
    }
  ],
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  "certificates": [],
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  "eu_market_availability": null,
  "properties": [
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}